Evaluation of an Effectiveness and Safety of the Electroacupuncture in the Management of Intractable Neuropathic Pain

Failed Back Surgery Syndrome Clinical Trial

Official title:

Evaluation of an Effectiveness and Safety of the Electroacupuncture in the Management of Intractable Neuropathic Pain: An Open-labeled, Single-arm, Exploratory Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03315598
• Other study ID #: 1703-024-836
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: February 23, 2018

Study information

• Verified date: September 2022
• Source: Seoul National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will evaluate the effectiveness and safety of acupuncture treatment in refractory neuropathic pain patients.

Description:

The purpose of this study was to evaluate the effectiveness of acupuncture treatment in the patients with the following neuropathic pain related syndrome.

• Postherpetic neuralgia

• Failed back surgery syndrome

• Diabetic neuropathy

• other peripheral neuropathy

Patients with refractory neuropathic pain who do not respond to conservative treatment for more than 3 months should be included. Acupuncture treatment is maintained for 2 months in oriental medicine hospital. The effect is evaluated through the numeric rating score and the validated questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 23, 2018
• Est. primary completion date: February 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who can adequately write a reportable questionnaire

• Patients who have been diagnosed with one of the following neuropathic pain disease (postherpetic neuralgia, failed back surgery syndrome, diabetic neuropathy, other peripheral neuropathy)

• Patients who failed conservative treatment at Seoul National University Hospital for more than 3 months.

• Patients with NRS 5 points or more

• Patients with painDETECT score 19 points or more

Exclusion Criteria:

• Patients with major mental illness

• Patients with unstable medical conditions

• Pregnant

• Patients who received acupuncture treatment at the site within the past month

• Patients with bleeding tendency

• Patients taking immunosuppressive drugs

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy, Painful
• Failed Back Surgery Syndrome
• Neuralgia
• Neuralgia, Postherpetic
• Neuralgia; Postherpetic

Intervention

Procedure:
• Electroacupuncture
lectroacupuncture is a form of acupuncture where a small electric current is passed between pairs of acupuncture needles. According to some acupuncturists, this practice augments the use of regular acupuncture, can restore health and well-being, and is particularly good for treating pain.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Numeric rating scale pain score (0-10) at 4 weeks	The Numeric Rating Scale (NRS) is an 11-point scale from 0 to 10 for patient self-reporting of pain. Change from the baseline NRS pain score at 4 weeks will be noted as percentage (%).	At 4-week follow-up visit
Primary	Change from baseline Numeric rating scale pain score (0-10) at 8 weeks	The Numeric Rating Scale (NRS) is an 11-point scale from 0 to 10 for patient self-reporting of pain. Change from the baseline NRS pain score at 4 weeks will be noted as percentage (%).	At 8-week follow-up visit
Secondary	Change from the score of the short-form McGill Pain Questionnaire at 8 weeks	The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors. The SF-MPQ also includes the Present Pain Intensity (PPI) index of the standard MPQ and a visual analogue scale (VAS).	At 8-week follow-up visit
Secondary	Change from baseline score of Brief Pain Inventory Short Form (BFI-SF) at 8 weeks	The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning.	At 8-week follow-up visit
Secondary	Patients' Global Impression of Change (PGIC) scale	The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment.; 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.	At 8-week follow-up visit
Secondary	5-pointed patient satisfaction scale	The 5-pointed patient satisfaction scale is an 5-point scale for patient self-reporting of satisfaction with treatment.; Very satisfied; Satisfied; Neither satisfied nor dissatisfied; Dissatisfied; Very dissatisfied	At 8-week follow-up visit